DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see page 2, filed 07/21/2025, with respect to the rejection(s) of claim(s) 1, 27, and 33 under 103 rejections over Keating in view of various references have been fully considered and are persuasive. Examiner agrees that the 103 rejection of modified Keating in view of Nicholas fails to disclose “wherein the plurality of openings substantially surround a body of the semi-permeable membrane” (claim 1), “the mesh membrane comprising a plurality of pores substantially covering the mesh membrane” (claim 27) and “a plurality of openings distributed throughout a majority of a surface area of the mesh membrane” (claim 33). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Keating et al. (US 20210402157) in view of Herbert et al. (US 20080065012), Nicholas et al. (US 5588962), and Beyar et al. (US 20160184526) for claim 1, Keating et al. (US 20210402157) in view of Herbert et al. (US 20080065012), Nicholas et al. (US 5588962), Beyar et al. (US 20160184526) and Chhabra et al. (US 20060079923) for claim 27 and Keating et al. (US 20210402157) in view of Herbert et al. (US 20080065012), Nicholas et al. (US 5588962), Chhabra et al. (US 20060079923), Beyar et al. (US 20160184526), and Hesselbjerg (US 20180071483) for claim 33.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “clot retention mechanism” in claims 1 and 27 and “a first delivery means”, “a proximal inflation means”, “a second delivery means”, “an expandable means”, and “a retention means” in claim 33.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-7. 21-23, 25-30, and 37-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “wherein the plurality of openings substantially surround a body of the semi-permeable membrane” in lines 10-12. The limitation reads as if the plurality of openings are apart of a separate element relative to the mesh membrane such that the plurality of openings can substantially surround the body of the mesh membrane. It is unclear to the examiner if the limitation is meant to further define the semi-permeable membrane in relation to the removal catheter since the semi-permeable membrane is claimed to be positioned around the removal catheter or in relation to a surface of the mesh membrane. For examination purposes, the limitation is interpreted as “wherein the semi-permeable membrane comprises a plurality of openings, wherein the plurality of openings substantially surround a surface of the semi-permeable membrane”.
Claim 27 recites the limitation “the mesh membrane comprising a plurality of pores substantially covering the mesh membrane” in lines 12-13. The limitation reads as if the plurality of pores are a part of a separate element relative to the mesh membrane such that the plurality of pores can substantially cover the mesh membrane. It is unclear to the examiner if the limitation is meant to further define the mesh membrane in relation to the removal catheter since the mesh membrane is claimed to be positioned around the removal catheter or in relation to a surface of the mesh membrane. For examination purposes, the limitation is interpreted as “the mesh membrane comprising a plurality of pores substantially covering a surface of the mesh membrane”.
Claim 37 recites the limitation “wherein the port is comprised of a plurality of ports, each of the plurality of ports being positioned on multiple sides of the removal catheter”. The limitation reads as if the singular port introduced in claim 1 includes multiple ports. It is unclear to the examiner how a single port is comprised of multiple ports and if the limitation is meant to further define the port as being one of a plurality of ports. It is also unclear to the examiner from the limitation “each of the plurality of ports” if the plurality of ports introduced in the previous line is meant to be multiple sets of plurality of ports or a single set of plurality of ports such that each port of the plurality of ports are positioned on multiple sides of the removal catheter. For examination purposes, the singular port of claim 1 is interpreted as “at least one port” such that limitation in claim 37 is interpreted as “wherein the at least one port is comprised of a plurality of ports, each port of the plurality of ports are positioned on multiple sides of the removal catheter”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-2, 4, 6, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012), Nicholas et al. (US 5588962) [hereinafter Nicholas], and Beyar et al. (US 20160184526) [hereinafter Beyar].
Regarding claim 1, Keating discloses a system 100A for removing a clot P from a vessel V (Figs. 3A-E, para. 0057-0061), comprising:
a first catheter 105 having a first proximal end (not shown, Fig. 3A, para. 0057), a first distal end 111 (Fig. 3A, para. 0041), and a first lumen 117 therebetween (Figs. 3A, 3C, para. 0041);
a proximal balloon 113 disposed at a first distal portion of the first catheter 105 (Fig. 3A, para. 0057);
a second catheter 121A having a second proximal end (not shown, Fig. 3A, para. 0057), a second distal end 107 (Fig. 3A, para. 0042), and an outer diameter less than an inner diameter of the first lumen 117 of the first catheter 105 (see Fig. 3C which illustrates the second catheter 121A having an outer diameter less than an inner diameter of the first lumen 117);
an expandable mechanism (interpreted as distal occlusion element 109) disposed at a second distal portion of the second catheter 121A (Fig. 3A, para. 0057);
a clot retention mechanism (interpreted as incision tool 123A configured to puncture/cut a lesion, Fig. 3A, para. 0059-0060; Note: the instant application constitutes “a clot retention mechanism” also as “a clot disruption mechanism”; see para. 0078-0079 of the instant application);
wherein, in a clot retention configuration, the clot retention mechanism 123A is distal to the proximal balloon 103 (Fig. 3D, para. 0060), wherein, in a clot removal configuration, the clot retention mechanism 123A is proximal to the proximal balloon 103 (Fig. 3E, para. 0061).
However, Keating fails to disclose an expandable clot retention mechanism comprising a removal catheter, and wherein, in a clot retention configuration, the clot retention mechanism is secured to the clot with an adhesive, and wherein, in the clot removal configuration, the clot retention mechanism is withdrawn and the clot is secured to the clot retention mechanism with the adhesive.
Herbert in the same field of endeavor teaches a clot retrieval device comprising a clot retention mechanism (see Figs. 1A-2B, para. 0072-0073) comprising a removal catheter 14, 24 and an expandable, inflatable, balloon 16, 26 positioned on the removal catheter (Figs. 1B, 2B, para. 0072-0073), wherein, in an expanded configuration (Figs. 1E-F), the balloon is expanded to engage with a clot (Figs. 1E-F, para. 0076), wherein, in a clot retention configuration, the balloon is distal to a catheter 10 and the clot is secured to balloon with an adhesive 243 disposed on an outer surface of the balloon (Figs. 1D-F, para. 0076), and wherein, in a clot removal configuration, the balloon is withdrawn and the clot is secured to the balloon with the adhesive (para. 0076).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the clot retention mechanism in Keating to include the clot retention mechanism comprising the removal catheter and adhesive coated balloon of Herbert in order to allow the clot retention mechanism to engage and loosen clot material in its expanded state and capture the clot material (para. 0076 of Herbert), thereby reducing the likelihood of the clot material detaching and entering the bloodstream (para. 0006-0007 of Hebert).
However, modified Keating fails to disclose the removal catheter including a port and a semi-permeable membrane positioned around the port, wherein the semi-permeable membrane comprises a plurality of openings, and wherein, in the expanded configuration, the adhesive is introduced through the port and at least a portion of the adhesive permeates the semi-permeable membrane to engage with the clot.
Nicholas in the same field of endeavor teaches an inflatable semi-permeable membrane comprising a plurality of openings (interpreted as balloon 8 comprising openings, pores, or channels which allows an agent to flow therethrough; col. 2 lines 59-61, col. 3 lines 32-38, col. 5 lines 12-18) positioned around a port 10 of a catheter 4 (Fig. 2a, col. 2 lines 59-61), wherein, in an expanded configuration, the adhesive is introduced through the port 10 (col. 4 lines 34-37) and at least a portion of the adhesive permeates the semi-permeable membrane to engage with the clot (col. 4 lines 1-8).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Nicholas (delivering an adhesive through the port and semi-permeable membrane of the removal catheter) to the clot retention mechanism of modified Keating would have yielded predicable results, namely, an alternative way of delivering adhesive to plaque on the vessel wall (col. 4 lines 1-8 of Nicholas). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
However, modified Keating in view of Nicholas fails to disclose wherein the plurality of openings substantially surround a body of the semi-permeable membrane.
Beyar in the same field of endeavor of balloon catheters (Figs. 2A-C, para. 0163) teaches that it is known in the art for a semi-permeable membrane 212 to include a plurality of openings substantially surrounding a body of the semi-permeable membrane (Fig. 2C, para. 0163) for the purpose of treating the surrounding wall of a blood vessel 200 (Figs. 2A-2C, para. 0161-0163).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of openings of semi-permeable membrane in modified Keating to surround the body of the semi-permeable membrane, as taught by Beyar, in order to allow the adhesive to treat the surrounding wall of the blood vessel (Figs. 2A-2C, para. 0161-0163 of Beyar) as opposed to treating only a portion of the wall of the blood vessel (see Fig. 2, col. 2 lines 59-61, col. 3 lines 32-38, col. 5 lines 12-18 of Nicholas).
Regarding claim 2, modified Keating discloses wherein the expandable mechanism 109 comprises a balloon (Figs. 3A, 3D, para. 0045 of Keating).
Regarding claim 4, modified Keating discloses all of the limitation set forth above in claim 1. Modified Keating further discloses that the first catheter 105 and/or second catheter 121A can comprise a vacuum lumen (para. 0049, 0061 of Keating). However, modified Keating fails to disclose wherein the clot retention mechanism comprises a vacuum.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the clot retention mechanism with a vacuum lumen as opposed to the first catheter or the second catheter, since it has been held that rearranging parts of an invention involves only routine skill in the art. Inre Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C.
Regarding claim 6, modified Keating discloses all of the limitation set forth above in claim 1. Modified Keating further discloses that the first catheter 105 can comprise a flushing lumen 119 for pressurized fluid (Figs. 3B-C, para. 0050, 0061 of Keating). However, modified Keating fails to disclose wherein the clot retention mechanism comprises pressurized fluid.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the clot retention mechanism with a flushing lumen for pressurized fluid as opposed to the first catheter, since it has been held that rearranging parts of an invention involves only routine skill in the art. Inre Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C.
Regarding claim 22, modified Keating discloses wherein the second catheter 121A comprises a pointed distal tip (see Figs. 3A, 3D of Keating which illustrates the second catheter 121A having a pointed distal tip).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert], Nicholas et al. (US 5588962) [hereinafter Nicholas], and Beyar et al. (US 20160184526) [hereinafter Beyar] as applied to claim 1 above, and further in view of Griffin (US 20050137622).
Regarding claim 3, modified Keating discloses all of the limitations set forth above in claim 1. However, modified Keating fails to disclose wherein the expandable mechanism comprises expandable tines.
Griffin in the same field of endeavor teaches a catheter comprising an expandable member 40 wherein the expandable member comprises expandable tines (interpreted as struts formed by cuts 80; Figs. 6-10, para. 0054, 0061) for the purpose of occluding vasculature (para. 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the expandable member in modified Keating for the expandable member comprising the expandable tines of Griffin, since such a substitution would yield the predictable result of occluding vasculature (para. 0049); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claims 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert], Nicholas et al. (US 5588962) [hereinafter Nicholas], and Beyar et al. (US 20160184526) [hereinafter Beyar] as applied to claim 1 above, and further in view of Agrawal (US 20120271231).
Regarding claims 7 and 21, modified Keating discloses all of the limitations set forth above in claim 1. Modified Keating further discloses that the first catheter 105 and/or second catheter 121A can be aspiration catheters (para. 0049, 0061 of Keating). However, Modified Keating fails to disclose a third catheter having a proximal end and a distal end and movable through a lumen of the first catheter, wherein the third catheter is an aspiration catheter.
Agrawal in the same field of endeavor teaches a thrombectomy system comprising a first thrombectomy catheter 20, a second occlusion catheter 40 disposed within the first catheter 20 (Fig. 1A, para. 0017), and a third aspiration catheter 60 having a proximal end and a distal end 63 and movable through a lumen 24 of the first catheter 20 (Fig. 1A, para. 0024).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of modified Keating such that the third catheter is the aspiration catheter instead of the first catheter, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C.
Claims 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert], Nicholas et al. (US 5588962) [hereinafter Nicholas], and Beyar et al. (US 20160184526) [hereinafter Beyar] as applied to claim 1 above, and further in view of Courtney et al. (US 20020016564) [hereinafter Courtney].
Regarding claim 23, modified Keating discloses all of the limitations set forth above in claim 1. However, Modified Keating fails to disclose wherein the removal catheter is movable through a second lumen of the first catheter.
Courtney teaches a first balloon catheter 102 (Fig. 3D) comprising an inner catheter movable through a first lumen 166 of the first catheter 102 and a treatment device 130 moveable through a second lumen 168 of the first catheter 102 (Fig. 3D, para. 0038, 0043), as a known alternative to the first catheter comprising only one lumen for delivery two devices (see Figs. 3A-B, para. 0041).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first catheter of modified Keating to include two device delivery lumens, as taught by Courtney, since the modification is a substitution for one balloon catheter for another. such that the third catheter is the aspiration catheter instead of the first catheter and since Courtney expressly disclose that the dual device delivery lumen catheter is a known alternative to the single device delivery lumen catheter. The substitution for one catheter configuration for another would yield the predictable result of a way to deliver multiple instruments through the first catheter (para. 0043); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 25, modified Keating discloses further comprising a reservoir (interpreted as fluid source 3) including the adhesive in fluid communication with a lumen of the removal catheter (Figs. 1, 2a, col. 2 lines 59-61, col. 3 lines 32-38, col. 5 lines 12-18 of Nicholas).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert], Nicholas et al. (US 5588962) [hereinafter Nicholas], Beyar et al. (US 20160184526) [hereinafter Beyar] and Courtney et al. (US 20020016564) [hereinafter Courtney] as applied to claim 25 above, and further in view of Teitelbaum (US 20160158500).
Regarding claim 26, modified Keating discloses all of the limitations set forth above in claim 25. However, modified Keating fails to disclose wherein the adhesive is comprised of N-butyl cyanoacrylate.
Teitelbaum teaches an anchor stent 50 that may be employed endovascularly and used for a variety of medical procedures such as stroke thrombectomy (para. 0013), the device 50 may also be used to infuse therapeutic particles and/or substances to a target site such as an adhesive comprising N-butyl cyanoacrylate (Fig. 5, para. 0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive in modified Keating to include the adhesive comprising N-butyl cyanoacrylate of Teitelbaum since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use (In re Leshin 125 USPQ 416; MPEP 2144.07).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012), Nicholas et al. (US 5588962) [hereinafter Nicholas], and Beyar et al. (US 20160184526) [hereinafter Beyar], as applied to claim 1 above, and further in view of Campbell (US 20020091435).
Regarding claims 37-38, modified Keating discloses all of the limitations set forth above in claim 1. However, modified Keating fails to disclose wherein the port is comprised of a plurality of ports, each of the plurality of ports being positioned on multiple sides of the removal catheter (claim 37) and a plurality of lumens, each of the plurality of lumens being in fluid communication with at least one of the plurality of ports (claim 38).
Campbell in the same field of endeavor of balloon catheters 10 teaches a catheter shaft 12 comprising a plurality of ports 32, 34 (Fig. 2, para. 0027), each of the plurality of ports being positioned on multiple sides of the catheter shaft 12 (see Fig. 2 which illustrates port 32 on a proximal side of the shaft and port 34 on a distal side the shaft), and a plurality of lumens (para. 0028, 0032), each of the plurality of lumens being in fluid communication with at least one the plurality of ports 32, 34 (para. 0028, 0032) for the purpose of inflating outer balloon 24 (Fig. 2, para. 0028).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Campbel (balloon inflation via. the plurality of ports and plurality of lumens) to the removal catheter of modified Keating would have yielded predicable results and resulted in an improved device, namely, a device that would have an increase in a rate of inflation due to the inclusion of the plurality of ports/lumens as opposed to a single port/lumen for inflation (Fig. 2, para. 0028 of Campbell); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012), Nicholas et al. (US 5588962) [hereinafter Nicholas], Beyar et al. (US 20160184526) [hereinafter Beyar], and Chhabra et al. (US 20060079923) [hereinafter Chhabra].
Regarding claim 27, Keating discloses a system 100A for removing a clot P from a vessel V (Figs. 3A-E, para. 0057-0061), comprising:
a first catheter 105 having a proximal end (not shown, Fig. 3A, para. 0057) and a distal end 111 (Fig. 3A, para. 0041) and at least one lumen 117 extending through the first catheter (Figs. 3A, 3C, para. 0041);
a proximal balloon 113 disposed at a distal portion of the first catheter 105 (Fig. 3A, para. 0057);
a second catheter 121A having a proximal end (not shown, Fig. 3A, para. 0057) and a distal end 107 (Fig. 3A, para. 0042) and being movable through the at least one lumen 117 in the first catheter (Fig. 3A, 0041, 0057), the distal end 107 of the second catheter 121A comprising a pointed tip (see Figs. 3A, 3D which illustrates the second catheter 121A having a pointed distal tip);
an expandable mechanism (interpreted as distal occlusion element 109) disposed at a distal region of the second catheter 121A (Fig. 3A, para. 0057);
a clot retention mechanism (interpreted as incision tool 123A configured to puncture/cut a lesion, Fig. 3A, para. 0059-0060; Note: the instant application constitutes “a clot retention mechanism” also as “a clot disruption mechanism”; see para. 0078-0079 of the instant application) disposed between the proximal balloon 113 and the expandable mechanism 109 (Fig. 3D),
However, Keating fails to disclose wherein an adhesive is used to secure the clot to an expandable clot retention mechanism for removal from a vessel by a removal catheter.
Herbert in the same field of endeavor teaches a clot retrieval device comprising a clot retention mechanism (see Figs. 1A-2B, para. 0072-0073) comprising a removal catheter 14, 24 and an expandable, inflatable, balloon 16, 26 positioned on the removal catheter (Figs. 1B, 2B, para. 0072-0073, wherein an adhesive 243 disposed on an outer surface of the balloon 16, 26 secures the clot to the balloon for removal from a vessel by the removal catheter (Figs. 1D-F, para. 0076).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the clot retention mechanism in Keating to include the clot retention mechanism comprising the removal catheter and adhesive coated balloon of Herbert in order to allow the clot retention mechanism to engage and loosen clot material in its expanded state and capture the clot material (para. 0076 of Herbert), thereby reducing the likelihood of the clot material detaching and entering the bloodstream (para. 0006-0007 of Hebert).
However, modified Keating fails to disclose the removal catheter including a first port and a mesh membrane positioned around the first port of the removal catheter, wherein, in a clot retention configuration, the adhesive is introduced into the mesh membrane through the first port such that the adhesive (2) permeates through the mesh membrane.
Nicholas in the same field of endeavor teaches an inflatable mesh membrane comprising a plurality of pores (interpreted as balloon 8 comprising openings, pores, or channels which allows an agent to flow therethrough; col. 2 lines 59-61, col. 3 lines 32-38, col. 5 lines 12-18) positioned around a port 10 of a catheter 4 (Fig. 2a, col. 2 lines 59-61), wherein, in a clot retention configuration, an adhesive is introduced into the mesh membrane 8 through the first port 10 such that the adhesive permeates through the mesh membrane to engage with a clot (Figs. 2a, 3a, col. 4 lines 1-8).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Nicholas (delivering an adhesive through the port and mesh membrane of the removal catheter) to the clot retention mechanism of modified Keating would have yielded predicable results, namely, an alternative way of delivering adhesive to plaque on the vessel wall (col. 4 lines 1-8 of Nicholas). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
Note: The combination proposed would result in a product comprising an adhesive introduced into the mesh membrane 240 of Hebert (Fig. 16, para. 0084 of Hebert) through the first port 10 of Nicholas (Fig. 2a, col. 2 lines 59-61 of Nicholas) such that the adhesive permeates through the mesh membrane, as taught by Nicholas, (Figs. 2a, 3a, col. 4 lines 1-8 of Nicholas) to secure the clot to the mesh membrane 240 for removal from a vessel by the removal catheter (Figs. 15B-16, para. 0083-0084 of Hebert).
However, modified Keating in view of Nicholas fails to disclose wherein the plurality of pores of the mesh membrane substantially covering the mesh membrane.
Beyar in the same field of endeavor of balloon catheters (Figs. 2A-C, para. 0163) teaches that it is known in the art for inflatable mesh membranes 212 to include a plurality of pores substantially covering the mesh membrane (Fig. 2C, para. 0163) for the purpose of treating the surrounding wall of a blood vessel 200 (Figs. 2A-2C, para. 0161-0163).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of pores of the mesh membrane in modified Keating to substantially cover the mesh membrane, as taught by Beyar, in order to allow the adhesive to treat the surrounding wall of the blood vessel (Figs. 2A-2C, para. 0161-0163 of Beyar) as opposed to treating only a portion of the wall of the blood vessel (see Fig. 2, col. 2 lines 59-61, col. 3 lines 32-38, col. 5 lines 12-18 of Nicholas).
However, modified Keating in view of Beyar fails to disclose that the adhesive is used to expand the mesh membrane.
Chhabra in the same field of endeavor teaches a balloon catheter (Fig. 1, para. 0070) comprising a mesh membrane (interpreted as microporous balloon 1 comprising micropores 7) (Fig. 3, para. 0076). The reference teaches that it’s known in the art to use an adhesive as an inflation fluid such that the adhesive expands the mesh membrane (Fig. 1, para. 0026, 0046, 0070, 0076).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Chhabra (using adhesive as an inflation fluid) to the clot retention mechanism of modified Keating would have yielded predicable results, namely, an alternative way to inflate and expand the mesh membrane with the adhesive in order to deliver the adhesive the target site (abstract, para. 0026, 0046, 0070, 0076 of Chhabra). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
Regarding claim 28, modified Keating discloses wherein the expandable mechanism 109 comprises a balloon (Figs. 3A, 3D, para. 0045 of Keating).
Claim 29 and 30 is rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert], Nicholas et al. (US 5588962) [hereinafter Nicholas], Beyar et al. (US 20160184526) [hereinafter Beyar], and Chhabra et al. (US 20060079923) [hereinafter Chhabra] as applied to claim 27 above, and further in view of Griffin (US 20050137622).
Regarding claim 29, modified Keating discloses all of the limitations set forth above in claim 27. However, modified Keating fails to disclose wherein the expandable mechanism comprises expandable tines.
Griffin in the same field of endeavor teaches a catheter comprising an expandable member 40 wherein the expandable member comprises expandable tines (interpreted as struts formed by cuts 80; Figs. 6-10, para. 0054, 0061) for the purpose of occluding vasculature (para. 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the expandable member in modified Keating for the expandable member comprising the expandable tines of Griffin, since such a substitution would yield the predictable result of occluding vasculature (para. 0049); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 30, modified Keating discloses wherein the plurality of expandable tines (interpreted as struts formed by cuts 80) comprises four expandable tines (Figs. 6-10, para. 0054, 0061 of Griffin).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012) [hereinafter Herbert], Nicholas et al. (US 5588962) [hereinafter Nicholas], Beyar et al. (US 20160184526) [hereinafter Beyar], and Chhabra et al. (US 20060079923) [hereinafter Chhabra] as applied to claim 27 above, and further in view of Chien et al. (US 20020077594) [hereinafter Chien].
Regarding claim 36, modified Keating discloses all of the limitations set forth above in claim 27. However, modified Keating fails to disclose a second port being positioned on a different side of the removal catheter than the first port.
Chien in the same field of endeavor teaches an angioplasty balloon catheter (Figs. 1A-B, para. 0047) comprising a plurality of inflation ports 22, wherein the plurality of ports includes a first port (interpreted as the port positioned on a proximal side of the catheter) and a second port (interpreted as the port positioned on a distal side of the catheter) being positioned on a different side of the removal catheter than the first port (Figs. 1A-B) for the purpose of passing inflation fluid into the interior of the balloon in order to inflate the balloon (para. 0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the removal catheter in modified Keating to include the second port being positioned on a different side of the removal catheter than the first port, as taught by Chien, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US 20210402157) [hereinafter Keating ‘157] in view of Herbert et al. (US 20080065012), Nicholas et al. (US 5588962) [hereinafter Nicholas], Beyar et al. (US 20160184526) [hereinafter Beyar], Chhabra et al. (US 20060079923) [hereinafter Chhabra], and Hesselbjerg (US 20180071483).
Regarding claim 33, Keating discloses a system 100A for removing a clot P from a vessel V (Figs. 3A-E, para. 0057-0061), comprising:
a first delivery means (interpreted as balloon guide catheter 105) having a first proximal end (not shown, Fig. 3A, para. 0057), a first distal end 111 (Fig. 3A, para. 0041), and a first lumen 117 therebetween (Figs. 3A, 3C, para. 0041);
a proximal inflation means (interpreted as proximal balloon 113) disposed at a first distal portion of the first catheter 105 (Fig. 3A, para. 0057);
a second delivery means (interpreted as inner tube 121A) having a second proximal end (not shown, Fig. 3A, para. 0057), a second distal end 107 (Fig. 3A, para. 0042), and an outer diameter less than an inner diameter of the first lumen 117 of the first delivery means 105 (see Fig. 3C which illustrates the second delivery means 121A having an outer diameter less than an inner diameter of the first lumen 117);
an expandable means (interpreted as distal occlusion element 109) disposed at a second distal portion of the second delivery means 121A (Fig. 3A, para. 0057);
a retention means for retaining a clot (interpreted as incision tool 123A configured to puncture/cut a lesion, Fig. 3A, para. 0059-0060; Note: the instant application constitutes “a clot retention mechanism” also as “a clot disruption mechanism”; see para. 0078-0079) and wherein, in a clot retention configuration, the retention means 123A is distal to the proximal inflation means 103 (Fig. 3D, para. 0060).
However, Keating fails to disclose an inflatable retention means comprising a removal catheter, and wherein, in a clot retention configuration, the retention means is secured to the clot with an adhesive, and wherein, in the clot removal configuration, the retention means is withdrawn and the clot is secured to the retention means with the adhesive.
Herbert in the same field of endeavor teaches a clot retrieval device comprising an inflatable retention means (see Figs. 1A-2B, para. 0072-0073) comprising a removal catheter 14, 24 and an expandable, inflatable, balloon 16, 26 positioned on the removal catheter (Figs. 1B, 2B, para. 0072-0073), wherein, in an inflated configuration (Figs. 1E-F), the balloon is expanded to engage with a clot (Figs. 1E-F, para. 0076), wherein, in a clot retention configuration, the balloon is distal to a catheter 10 and the clot is secured to balloon with an adhesive 243 disposed on an outer surface of the balloon (Figs. 1D-F, para. 0076), and wherein, in a clot removal configuration, the balloon is withdrawn and the clot is secured to the balloon with the adhesive (para. 0076).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the retention means in Keating to include the inflatable retention means comprising the removal catheter and adhesive coated balloon of Herbert in order to allow the retention means to engage and loosen clot material in its expanded state and capture the clot material (para. 0076 of Herbert), thereby reducing the likelihood of the clot material detaching and entering the bloodstream (para. 0006-0007 of Hebert).
However, modified Keating fails to disclose the removal catheter including a distal tip, a port, and a mesh membrane positioned around the port, wherein, in an inflated configuration, at least a portion of the adhesive permeates the mesh membrane to engage with the clot.
Nicholas in the same field of endeavor teaches an inflatable mesh membrane comprising a plurality of openings (interpreted as balloon 8 comprising openings, pores, or channels which allows an agent to flow therethrough; col. 2 lines 59-61, col. 3 lines 32-38, col. 5 lines 12-18) positioned around a port 10 of a catheter 4 (Fig. 2a, col. 2 lines 59-61), wherein, in an inflated configuration, at least a portion of the adhesive permeates the mesh membrane to engage with the clot (col. 4 lines 1-8).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Nicholas (delivering an adhesive through the port and mesh membrane of the removal catheter) to the retention means of modified Keating would have yielded predicable results, namely, an alternative way of delivering adhesive to plaque on the vessel wall (col. 4 lines 1-8 of Nicholas). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
Note: The combination proposed would result in a product comprising an adhesive introduced into the mesh membrane 240 of Hebert (Fig. 16, para. 0084 of Hebert) through the first port 10 of Nicholas (Fig. 2a, col. 2 lines 59-61 of Nicholas) such that the adhesive permeates through the mesh membrane, as taught by Nicholas, (Figs. 2a, 3a, col. 4 lines 1-8 of Nicholas) to secure the clot to the mesh membrane 240 for removal from a vessel by the removal catheter (Figs. 15B-16, para. 0083-0084 of Hebert).
However, modified Keating in view of Nicholas fails to disclose wherein the plurality of openings are distributed throughout a majority of a surface area of the mesh membrane.
Beyar in the same field of endeavor of balloon catheters (Figs. 2A-C, para. 0163) teaches that it is known in the art for a mesh membrane 212 to include a plurality of openings distributed throughout a majority of a surface area of the mesh membrane (Fig. 2C, para. 0163) for the purpose of treating the surrounding wall of a blood vessel 200 (Figs. 2A-2C, para. 0161-0163).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of openings of the mesh membrane in modified Keating to be distributed throughout the majority of the surface area of the mesh membrane, as taught by Beyar, in order to allow the adhesive to treat the surrounding wall of the blood vessel (Figs. 2A-2C, para. 0161-0163 of Beyar) as opposed to treating only a portion of the wall of the blood vessel (see Fig. 2, col. 2 lines 59-61, col. 3 lines 32-38, col. 5 lines 12-18 of Nicholas).
However, modified Keating in view of Beyar fails to disclose wherein, in the inflated configuration, the semi-permeable membrane is expanded by an adhesive introduced through the port.
Chhabra in the same field of endeavor teaches a balloon catheter (Fig. 1, para. 0070) comprising a mesh membrane (interpreted as microporous balloon 1 comprising micropores 7) (Fig. 3, para. 0076). The reference teaches that it’s known in the art to use adhesive as an inflation fluid such that in an inflated configuration, the mesh membrane 1 is expanded by the adhesive introduced through a port 2 (Fig. 1, para. 0026, 0046, 0070, 0076).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Chhabra (using adhesive as an inflation fluid) to the retention means of modified Keating would have yielded predicable results, namely, an alternative way to inflate and expand the mesh membrane with the adhesive in order to deliver the adhesive the target site (abstract, para. 0026, 0046, 0070, 0076 of Chhabra). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
However, modified Keating in view of Chhabra fails to disclose the mesh membrane positioned around the distal tip;
Hesselbjerg teaches a balloon catheter used for delivering therapeutic fluid to a target site (Figs. 1-2, para. 0008, 0088) comprising a balloon 6 positioned around a distal tip 5 of a catheter 2 (para. 0088) as a known alternative to a balloon arranged on a catheter such that the distal tip of the catheter extends beyond the balloon (para. 0088).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the mesh membrane and catheter arrangement of the retention means in modified Keating such that the mesh membrane is positioned around the distal tip of the removal catheter, as taught by Hesselbjerg, since Hesselbjerg expressly teaches that the arrangements are known alternatives of each other (para. 0088 of Hesselbjerg) and the modification is a substitution for one known balloon arrangement for another. The substitution would yield the predictable result of an alternative way to construct a balloon catheter; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 34, modified Keating discloses wherein the port 10 is positioned at a distal end of the removal catheter 4 (see Figs. 2a, 3a, of Nicholas; Note: the position of the port 10 on the distal end of the removal catheter is analogous to the position of the port 227 in the instant application, see Fig. 5, para. 0048 of the instant application).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Thursday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN DUBOSE/Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771